Day 2

All times are in Eastern time

Wednesday, March 6

11:00 AM

FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05 AM–12:20 PM

Biosimilar Biological Products
Krista Hessler Carver, Partner, Covington & Burling LLP

12:20–12:30 PM

Break

12:30–1:30 PM

Post-Approval Pharmacovigilance
David L. Rosen, Partner, Foley & Lardner LLP

1:30–1:40 PM

Break

1:40–2:40 PM

Regulation of Biological Manufacturing
Seth Olson, Associate, Latham & Watkins LLP

2:40–2:50 PM

Break

2:50–3:50 PM

Regulation of Biological Product Marketing
Kathryn Culver, Associate, Latham & Watkins LLP

3:50–4:00 PM

Break

4:00–5:00 PM

Violations, Enforcement, and International Issues
David L. Chesney, Principal and GM, DL Chesney Consulting, LLC

5:00 PM

Adjournment